1. Field of the Invention
Embodiments of the present invention relates to systems and methods for the rapid identification and/or verification of pharmaceuticals using spectroscopic techniques. More particularly, some embodiments of the present invention relate to analyzing filled prescriptions using Raman Spectroscopy through closed bottles.
2. Background Information
Most states in the U.S. require that a registered pharmacist confirm whether a pharmaceutical delivered to a customer is indeed the pharmaceutical prescribed by the physician. Typically, such confirmation is accomplished by the pharmacist visually inspecting the dispensed pharmaceutical to verify its correctness. In fact, pharmacists can spend as much as 50% of their time visually verifying prescriptions.
Despite such pharmacist verification, errors are not uncommon, especially during peak operating hours. For example, according to the National Association of Boards of Pharmacy, as many as 5% of the 3 billion prescriptions filled each year are incorrect. These erroneous prescriptions are responsible for as many as 7,000 deaths annually in the United States. Further, due to a steadily decreasing number of pharmacists, and an expected increase in the annual demand for prescriptions to nearly 5 billion, the number of instances in which a customer receives the wrong prescription is anticipated to increase.
Not surprisingly, increasing prescription errors have resulted in a growing collection of consumer complaints about potentially serious errors such as wrong counts, wrong drugs and/or wrong dosages. Accompanying the increase in complaints are dramatically increased litigation costs associated with errors filling prescriptions. Thus, there is a strong need for a system to replace the present manual verification technique and allow the verification and validation steps to be performed automatically and more reliably. A by-product of such an automatic verification system is freeing up pharmacists' time so they can provide better service to their customers.
Several conventional automatic prescription verification techniques have been developed to address the problems with manual prescription verification. For example, conventional automatic visual verification techniques rely on comparing an electronic image of the prescribed medication, i.e., a picture of the prescribed medication retrieved from a data library, to the actual medication that is to be dispensed to a customer. However, conventional automatic visual identification methods rely on the incorrect assumption that all pharmaceuticals are visually distinct. Not only aren't all pharmaceuticals visually distinct, but the differences between even visually distinct pharmaceuticals may be so subtle that errors are likely occur. Finally, because automatic visual verification systems are somewhat duplicative of the manual visual verification technique described above, such systems are susceptible to the same drawbacks of manual verification systems, particularly the possibility of human error.
Spectroscopic analysis is a more reliable method of validating dispensed pharmaceuticals than using visual techniques. Spectroscopic techniques rely on a unique spectral signature exhibited by each pharmaceutical such as a pill, tablet, capsule, gelcap, gel and liquid. Accepted spectroscopic techniques for pharmaceutical verification include Near-Infrared (NIR) spectroscopy, UV and visible spectroscopy, Raman spectroscopy and Fourier Transform Infrared (FT-IR) spectroscopy.
For example, U.S. Pat. No. 6,771,369 to David Rzasa et. al. (the “Rzasa patent”) discloses a specific method for pharmaceutical verification based on NIR spectroscopy for pharmacy validation and inspection. The Rzasa patent discloses a system in which the pharmacist opens the cap of the prescription vial or bottle containing the pharmaceuticals and places the vial or bottle under a NIR spectrometer. The system then obtains an NIR spectroscopic signature of the prescription and compares that signature to a database of signatures corresponding to known pharmaceuticals. The system verifies the prescription if the measured signature matches the signature in the database corresponding to the prescribed pharmaceutical.
However, the system described in the Rzasa patent suffers from several important drawbacks, including requiring the vial to be opened (and thus exposing the medicine to contamination), requiring roughly the same amount of time as with a visual inspection, and providing no chain of custody between the customer and the verified prescription, and thus no audit trail for forensic purposes. Furthermore, the NIR system described in the Rasza patent requires long integration times and lacks sufficient spectral contrast to uniquely, rapidly and repeatably identify a large number of pharmaceuticals accurately.